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FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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3 recalls that day

Fresenius Kabi Ivenix Infusion System LVP Software

The Ivenix Infusion System LVP Software has instructions for LVP duration programming that are emphasized in the IFU.

Moderate risk, FDA, Software defect

HANGZHOU BEVER MEDICAL DEVICES BD Ready-to-Use Hydrophilic Catheter

The BD Ready-to-Use Hydrophilic Catheter has a labeling error with an incorrect expiration date.

Moderate risk, FDA, Labeling error

Medline Kits With B. Braun IV Administration Sets

Medline kits containing B. Braun IV administration sets may have check valves that stick.

Moderate risk, FDA, Device defect

5 recalls that day

Medicrea IB3D Universal Implant Inserter and PL Instruments Set

Medicrea IB3D Universal Implant Inserter and PL Instruments Set may have a handle that untreads, causing inability to rotate implant.

Moderate risk, FDA, Device defect

Medtronic Neuromodulation Vanta Clinician Programmer Application

The A71200 Vanta Clinician Programmer Application does not function as intended during use, potentially causing a prolonged or postponed surgical procedure.

Moderate risk, FDA, Device defect

Mobius Imaging AIRO Computed Tomography X-Ray System Pendants

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Moderate risk, FDA, Labeling error

GE Medical Systems Israel Emission Computed Tomography Systems

Certain Nuclear Medicine systems could have been transported without adequate detector support, potentially causing a detector fall and life-threatening injury.

Moderate risk, FDA, Device defect

Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters

The Coyote balloon catheter may not inflate or deflate properly during use.

Moderate risk, FDA, Device defect

11 recalls that day

BD Pyxis ES Enterprise Server

The BD Pyxis ES Enterprise Server has a software issue that may result in equipment not receiving timely updates.

Moderate risk, FDA, Software defect

Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor and USB 2-Channel IBP Module

The Philips Tempus Pro Patient Monitor measures intracranial and bladder pressure, but these measurements have not been tested for accuracy.

Moderate risk, FDA, Device defect

Sophysa Pressio 2 ICP Monitoring System

The Pressio 2 ICP Monitoring System can reboot, causing customer complaints.

Moderate risk, FDA, Device defect

Abiomed Impella 5.5 with SmartAssist S2

The Impella 5.5 with SmartAssist S2 Set is packaged in an incorrect outer box carton.

Moderate risk, FDA, Device defect

Integra LifeSciences Codman Microsensor and CereLink ICP Sensor Basic Kits

The Codman Microsensor Basic Kit may have corrosion stains on its included needle.

Moderate risk, FDA, Device defect

Securitas Arial 900 MHz Call Stations

Arial 900 MHz Call Stations may fail to transmit a low battery alert before battery failure.

Moderate risk, FDA, Software defect

Medline Hudson RCI Medium Concentration Oxygen Masks

Oxygen masks have tubing that can disconnect, which may delay patient care and cause shortness of breath leading to hypoxia.

Moderate risk, FDA, Device defect

IMRIS HFD100 Head Fixation Device

The Head Fixation Device HFD100 has a torque screw that may crack or separate, risking patient injury.

Moderate risk, FDA, Device defect

Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor

The MX40 device could not reconnect when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

Moderate risk, FDA, Device defect

Siemens LUMINOS Lotus Max and Luminos dRF Max

Luminos Lotus Max and Luminos dRF Max systems may have incorrect collimation when switching quickly between organ programs.

Moderate risk, FDA, Software defect

Philips Incisive CT

Philips Incisive CT may have an incomplete scan due to an unstable connection inside the floating sensor.

Moderate risk, FDA, Device defect

1 recall that day

Vision RT AlignRT InBore System

The AlignRT InBore system has an omission in its Instructions for Use regarding laser information.

Moderate risk, FDA, Device defect

1 recall that day

Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems

Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.

Moderate risk, FDA, Device defect

1 recall that day

Meridian Bioscience Revogene C. Difficile Assay

The Revogene C. difficile assay may give false-negative results due to declining performance over time.

Moderate risk, FDA, Device defect

3 recalls that day

Halyard Organ Recovery OR Pack and Mini Plus Kit South

Halyard Organ Recovery OR Pack and Halyard Mini Plus Kit South are not suitable for organ transplant.

High risk, FDA, Device defect

Roche Diagnostics Elecsys Anti-TSHR Immunoassay

The Elecsys Anti-TSHR immunoassay gives results that vary by platform and calibrator lot, which may lead to delayed or incorrect diagnosis and treatment.

Moderate risk, FDA, Device defect

Applied Medical Kii Low Profile Bladed Dual Pack

Kii Low Profile, Bladed Dual Pack has a potential for extended blade obturator length after assembly.

Moderate risk, FDA, Device defect

1 recall that day

Abbott Diabetes Care FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors

Abbott Diabetes Care sensors may give incorrect low glucose readings due to a manufacturing issue.

High risk, FDA, Device defect